The technology used in the Omron HEM-7250-IT, to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|ESH (Europe)||Self-measurement||Published evidence|
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices: Omron HEM-7252G-HP and Omron HEM-7251G for self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Oct;20(5):286-90. Epub: 2015 Apr 29. doi: 0.1097/MBP.0000000000000127. PMID: 25932887.
ESH-IP:2010 - Pass General population